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REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy

NCT00087646 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 948

Last updated 2016-01-14

Study results available
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Summary

This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Ribavirin

1000/1200mg po daily for 72 weeks

DRUG

Ribavirin

1000/1200mg po daily for 48 weeks

DRUG

peginterferon alfa-2a [Pegasys]

360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks

DRUG

peginterferon alfa-2a [Pegasys]

360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks.

DRUG

peginterferon alfa-2a [Pegasys]

180 micrograms sc weekly for 72 weeks

DRUG

peginterferon alfa-2a [Pegasys]

180 micrograms sc weekly for 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Portugal
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00087646 on ClinicalTrials.gov